Diversifying towards a sustainable pharmaceutical group. Balancing growth and expansion in a challenging operating environment.
The approval of SCENESSE® (afamelanotide 16mg) for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP) by the US Food and Drug Administration (FDA) in October 2019 was a significant milestone for CLINUVEL. It satisfied a desire for regulatory endorsement that had been expressed 42 years ago. It enabled the negotiations with US insurers allowing reimbursement and distribution of SCENESSE® (started April 2020), which has contributed to further growth in revenues and profit.
The FDA’s outcome – foremost – opened the doors for CLINUVEL to expand the application of its expertise and know-how on the melanocortin family of molecules in key functions of the body.
In FY2021, CLINUVEL commenced to expand the product portfolio and develop an active clinical program aimed at the treatment of multiple indications with unmet or underserved needs and continued this strategy in FY2022. CLINUVEL has balanced the growth of commercial operations and the expansion of the drug portfolio and clinical program during the most challenging operating environment seen for decades. The achievement of a sixth consecutive annual profit in FY2022 and a strong balance sheet, reflects the value of the proven strategy and integrated business model, the commitment and longevity of management and led by an effective Board.
CLINUVEL will continue in FY2023 and beyond to balance the objectives of growth and expansion to diversify towards a sustainable specialised melanocortin pharmaceutical group to create long-term value for the benefit of all stakeholders.